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Phase 1: Sponge on a String 25 mm 10 pores/inch for Barrett's Esophagus
N/A
Waitlist Available
Led By Prasad G Iyer, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of the capsule sponge administration
Awards & highlights
Study Summary
This trial is testing a new device to see if it's a non-invasive way to evaluate patients with Barrett's Esophagus, which is a condition where the lining of the esophagus changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours of the capsule sponge administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of the capsule sponge administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
DNA Yield
Mucosal Irritation
Number of Subjects That Would Have This Procedure Again
+1 moreSecondary outcome measures
Barrett Esophagus
Barrett Esophagus
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2: Controls - No Barrett's EsophagusExperimental Treatment3 Interventions
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Group II: Phase 2: Cases - Barrett's EsophagusExperimental Treatment3 Interventions
In phase 2 of the study, additional subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Group III: Phase 1: Sponge on a String 25 mm 20 pores/inchExperimental Treatment4 Interventions
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Group IV: Phase 1: Sponge on a String 25 mm 10 pores/inchExperimental Treatment4 Interventions
In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Swallowable Sponge Cell Sampling Device
2015
N/A
~260
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 2
~1920
Endoscopic Procedure
2015
N/A
~250
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,809 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,404 Total Patients Enrolled
Exact Sciences CorporationIndustry Sponsor
31 Previous Clinical Trials
257,098 Total Patients Enrolled
Frequently Asked Questions
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